ReCord Study: Study Enrollment, Study Status and Progress



Study Enrollment: Study Approaching and Screening


Below summary outlined how potential subjects were screened, approached, enrolled and consented. The reasons why some potential subjects were not consented

1 Four groups

Total cases: 236 (by 9/5/2023)

  • 1. All cases: 236
  • 2a. Not contacted by mail or phone: 47
  • 2. Consent not sent: 120
  • 3. Agreed in principle/considered cord blood available: 20
  • 4. Consented: 45

Other: 4 has consent but has not agreed in principle; 1: did not bank cord but NBS in TX

All Cases: States of Birth, Diagnosis, and Residence

1 States of birth: US born

2 States of diagnosis/Treatment: US born

3 States of residence: US born



All Cases: Cord Blood Bank and Blood Spot

1 Blood bank types: Consented VS Not yet

2 Blood bank types: Cord blood received VS Not yet received

3 Blood spot availability as of Fall 2023



All Cases: Leukemia Diagnosis

1 ALL Vs AML

2 Morphology

3 ALL Vs AML by Groups

4 Immunophenotype by Groups



All Cases: Four Group’s Age at Diagnosis, Diagnosis Year, Sex, Race/Ethnicity

1 Age at diagnosis

  • Total cases



- Total cases by Groups

2 Diagnosis year

  • Total cases



- Total cases by Groups

3 Race/Ethnicity

  • Total cases



- Total cases by Groups in ALL



- Total cases by Groups in AML

4 Sex

  • Total cases



- Total cases by Groups



Siblings

1 All cases: siblings

Characteristic N = 22
How many siblings, including full and half-siblings, does this child have?
1 11 (50%)
2 7 (32%)
3 3 (14%)
4 1 (4.5%)
Have any of the child’s siblings had cancer?
No 21 (95%)
Yes 1 (4.5%)
Who was diagnosed with cancer?
full sister 1 (100%)
Unknown 21
What type of cancer was he/she diagnosed with?
Acute lymphoblastic leukemia 1 (100%)
Unknown 21
How old was he/she when the cancer was diagnosed?
3 1 (100%)
Unknown 21
Have any other of child’s siblings had cancer?
No 1 (100%)
Unknown 21
1 n (%)

2 Twin siblings

Characteristic N = 6
ALL_AML
Lymphoblastic Leukemia 5 (83%)
Myeloid Leukemia 0 (0%)
NA 1 (17%)
Diagnosis (MORPHOLOGY) ICD-O CODE
9836-3 Precursor B-cell lymphoblastic leukemia (see also M-9728-3) 4 (100%)
Missing 2
Parental report of leukemia type pre-Central Review
ALL 1 (100%)
Missing 5
Age
2 2 (40%)
3 2 (40%)
12 1 (20%)
Missing 1
Year
2017 1 (20%)
2018 1 (20%)
2019 1 (20%)
2021 1 (20%)
2023 1 (20%)
Missing 1
Race
Asian 0 (0%)
Black 0 (0%)
Hispanic 0 (0%)
Other 0 (0%)
Unknown 0 (0%)
White 2 (100%)
Missing 4
Sex
Female 1 (20%)
Male 4 (80%)
Missing 1
1 n (%)



Study Status: Four Groups of Consented Subjects


Below summary outlined life cycles of consented study participates, their demographics, clinical variables and questionnaire responses

1 Study status

  • Consented: 45 (by 9/5/2023)
  • HIPAA completed: 39
  • Questionnaire completed: 29
  • Cord blood received: 20

2 Four consented groups

The consented participants were categorized into four groups based on their different status of cord blood requisition.

  • Have cord: 16
  • Cord in process: 9
  • Cord uncertain: 9
  • Cord inaccessible: 11

3 Patients identified by COG vs. Volunteers

4 Blood spot availability as of Fall 2023

  • 14 consented patients had blood spot available in Fall 2023.
  • Among 9 patients had cord blood inaccessible but 3 of them will have blood spot be collected in fall 2023.

## NULL





Consented Participants: EPI and Lab Data Requisition and Retrieval

1 EPI record requisition and retrieval

Characteristic Overall, N = 451 Lymphoblastic Leukemia, N = 361 Myeloid Leukemia, N = 91 NA, N = 01
Questionnaire completed
    Complete 29 (64%) 21 (58%) 8 (89%) 0 (NA%)
    Incomplete 16 (36%) 15 (42%) 1 (11%) 0 (NA%)
Residential history completed
    Complete 23 (51%) 17 (47%) 6 (67%) 0 (NA%)
    Incomplete 22 (49%) 19 (53%) 3 (33%) 0 (NA%)
Prenatal and delivery record status
    Received complete 10 (83%) 7 (78%) 3 (100%) 0 (NA%)
    Sent 2 (17%) 2 (22%) 0 (0%) 0 (NA%)
    Unknown 33 27 6 0
Initial Request Status
    Needs follow-up w/ institution or case 2 (4.8%) 1 (3.0%) 1 (11%) 0 (NA%)
    Pre-payment Required 1 (2.4%) 1 (3.0%) 0 (0%) 0 (NA%)
    Ready to request 13 (31%) 10 (30%) 3 (33%) 0 (NA%)
    Received - Ready for review 25 (60%) 20 (61%) 5 (56%) 0 (NA%)
    Requested 1 (2.4%) 1 (3.0%) 0 (0%) 0 (NA%)
    Unknown 3 3 0 0
Medical Records Requested?
    Yes 27 (100%) 22 (100%) 5 (100%) 0 (NA%)
    Unknown 18 14 4 0
1 n (%)



2 Specimen requisition and retrieval

3 Tumor specimens available at BPC

  • Tumor samples are available through COG BPC: 27 (by 9/5/2023)
  • Tumor samples are not available through COG BPC: 10
  • Requested-In progress: 4
  • Volunteers-no COG number to use to request: 3
  • Consented-Ready to request: 1



Consented Participants: Leukemia Diagnosis

1 ALL Vs AML

2 Morphology

3 Immunophenotype by Groups

4 Volunteer parental report of leukemia diagnosis



Consented Participants: Four Groups’ Age, Diagnosis Year, Sex, Race/Ethnicity

1 Age at diagnosis

2 Diagnosis year

3 Race/Ethnicity

4 Sex



Consented Participants: Questionnaire Item Frequencies


29 subjects completed questionnaires.

Characteristic Overall, N = 29 Lymphoblastic Leukemia, N = 21 Myeloid Leukemia, N = 8 NA, N = 0 p-value
Birth Weight (grams) >0.9
Mean(SD) 3149(514) 3137(562) 3175(420) NA(NA)
Missing 3 3 0 0
Was this a Cesarean or a vaginal delivery? 0.4
Cesarean 11(38) 7(33) 4(50) 0(NA)
Vaginal 18(62) 14(67) 4(50) 0(NA)
For how long were you in labor? (The time from when regular, moderately strong contractions began until birth.) 0.2
11 to < 13 hours 2(33) 0(0) 2(67) 0(NA)
5 to < 7 hours 2(33) 2(67) 0(0) 0(NA)
7 to < 9 hours 1(17) 0(0) 1(33) 0(NA)
9 to < 11 hours 1(17) 1(33) 0(0) 0(NA)
Missing 23 18 5 0
Was this child breast fed? 0.15
No 6(21) 6(29) 0(0) 0(NA)
Yes 23(79) 15(71) 8(100) 0(NA)
Was this a single birth or was he/she one of twins or triplets, etc.? >0.9
Single birth 28(97) 20(95) 8(100) 0(NA)
Twins 1(3.4) 1(4.8) 0(0) 0(NA)
BEFORE AGE 6, did this child ever regularly attend, for at least 2 months, any kind of child care (daycare or preschool) where other children were present? Regularly is once a week or more >0.9
No 5(17) 4(19) 1(13) 0(NA)
Yes 24(83) 17(81) 7(88) 0(NA)
About how much weight did mom gain? 0.2
Mean(SD) 280(433) 321(455) 166(367) NA(NA)
Missing 2 1 1 0
Did mom EVER drink at least TWO DRINKS PER MONTH for a period of ONE YEAR OR LONGER? 0.7
No 12(41) 8(38) 4(50) 0(NA)
Yes 17(59) 13(62) 4(50) 0(NA)
Has mom ever smoked even one cigarette in mom’s entire life? >0.9
No 17(59) 12(57) 5(63) 0(NA)
Yes 12(41) 9(43) 3(38) 0(NA)
1 n(%)
2 Wilcoxon rank sum test; Fisher’s exact test



Translocations: Central and Institutional Review Reports and Project for Everychild

1 Central and Institutional Review Reports

2 Project for Everychild

Characteristic Overall, N = 86 Lymphoblastic Leukemia, N = 82 Myeloid Leukemia, N = 4 p-value
AGE AT DIAGNOSIS >0.9
Mean(SD) 6.4(5.0) 6.4(5.0) 6.3(5.7)
Hypodiploidy
Indeterminate 1(100) 1(100) 0(NA)
No presence 85 81 4
Trisomy 4
Trisomy 4 24(100) 24(100) 0(NA)
No presence 62 58 4
Trisomy 10
Trisomy 10 24(100) 24(100) 0(NA)
No presence 62 58 4
ETV6-RUNX1
ETV6-RUNX1 12(100) 12(100) 0(NA)
No presence 74 70 4
RUNX1T1
RUNX1T1 1(100) 0(NA) 1(100)
No presence 85 82 3
KMT2A (MLL) rearrangement
KMT2A (MLL) rearrangement 6(100) 5(100) 1(100)
No presence 80 77 3
t(9;22)(q34;q11.2) BCR-ABL1
t(9;22)(q34;q11.2) BCR-ABL1 2(100) 2(100) 0(NA)
No presence 84 80 4
Other translocation involving 11q23 >0.9
Add(11)(q23) 1(20) 1(25) 0(0)
Inv(11)(q14q23) 1(20) 1(25) 0(0)
T(11;19)(q23;p13.3) 1(20) 1(25) 0(0)
T(11;19)(Q23;P13.3) 1(20) 1(25) 0(0)
t(9;11)(p22;q23) 1(20) 0(0) 1(100)
No presence 81 78 3
CEP8
CEP8 1(100) 0(NA) 1(100)
No presence 85 82 3
PML-RARA
PML-RARA 1(100) 0(NA) 1(100)
No presence 85 82 3
Double trisomy
Double trisomy 17(100) 17(100) 0(NA)
No presence 69 65 4
Abnormality +8
Translocations +8 1(100) 0(NA) 1(100)
No presence 85 82 3
t(15;17)
t(15;17) 1(100) 0(NA) 1(100)
No presence 85 82 3
t(5;8)(q22;q21.2)
t(5;8)(q22;q21.2) 1(100) 0(NA) 1(100)
No presence 85 82 3
1 n(%)
2 Wilcoxon rank sum test; Fisher’s exact test